benzonatate

Generic: benzonatate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler precision dose, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-798
Product ID 68094-798_02b6bfad-6cc9-4e9e-9320-3ba093f5ae8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202765
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

Established (EPC)
non-narcotic antitussive [epc]
Physiologic Effect
decreased tracheobronchial stretch receptor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094798
Hyphenated Format 68094-798

Supplemental Identifiers

RxCUI
197397 283417
UPC
0368094901505 0368094798501
UNII
5P4DHS6ENR
NUI
N0000009010 N0000175796

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benzonatate (source: ndc)
Generic Name benzonatate (source: ndc)
Application Number ANDA202765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68094-798-50)
  • 500 CAPSULE in 1 BOTTLE (68094-798-60)
source: ndc

Packages (2)

68094-798-50 100 CAPSULE in 1 BOTTLE (68094-798-50) 68094-798-60 500 CAPSULE in 1 BOTTLE (68094-798-60)

Ingredients (1)

benzonatate (100 mg/1)

Linked Drug Pages (1)

Benzonatate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02b6bfad-6cc9-4e9e-9320-3ba093f5ae8b", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0368094901505", "0368094798501"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["978d0c83-bc01-49b2-a08a-61d72ee58ff8"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68094-798-50)", "package_ndc": "68094-798-50", "marketing_start_date": "20240301"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68094-798-60)", "package_ndc": "68094-798-60", "marketing_start_date": "20240301"}], "brand_name": "Benzonatate", "product_id": "68094-798_02b6bfad-6cc9-4e9e-9320-3ba093f5ae8b", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "68094-798", "generic_name": "Benzonatate", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA202765", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}